Long-term efficacy and safety profile of Eylea™ 8 mg with extended dosing intervals in diabetic macular edema confirmed at three years
Saturday, October 19, 2024
Bayer and its collaboration partner Regeneron presented results from the open-label extension study of the clinical trial PHOTON in patients with diabetic macular edema (DME) at three years, in a late-breaking session at the American Academy of Ophthalmology Annual Meeting, 18-21 October, Chicago, USA. Patients randomized to Eylea 8 mg from baseline maintained their visual and anatomic improvements at the end of three years, with the vast majority of patients on extended dosing intervals of ≥ 3 months. 45% of patients had a last completed dosing interval of ≥ 5 months, and 25% completed a last dosing interval of 6 months at the end of three years. Notably, patients switched to Eylea 8 mg demonstrated substantially slower fluid reaccumulation after their first Eylea 8 mg dose, as compared to their previous rate of fluid reaccumulation with Eylea 2 mg. The safety profile of Eylea 8 mg continued to be favorable in the third year.
“These long-term results are unprecedented and demonstrate that Eylea 8 mg successfully achieves sustained disease control with extended treatment intervals for the vast majority of patients in a setting similar to real-world clinical practice,” said Diana Do, MD, Professor of Ophthalmology and Vice Chair for Clinical Affairs at the Byers Eye Institute, Stanford University, USA. “Based on the positive data Eylea 8 mg has the potential to become the new standard of care therapy in diabetic macular edema.”
“Eylea 8 mg, truly addresses a significant unmet need to extend the treatment interval for patients with diabetic macular edema,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceuticals Leadership Team at Bayer. “This will help reduce the burden of disease on patients, improve treatment adherence, and alleviate capacity constraints in eye care clinics.”
Eylea 8 mg has the potential to extend treatment intervals for all DME-patients. Efficacy evaluated by mean change in best-corrected visual acuity (BCVA) was maintained in all Eylea 8 mg patient groups throughout the third year (week 156) compared to the start of the extension study (baseline at week 96).
The safety profile of Eylea 8 mg continued to be favorable in the third year and is consistent with the well-established safety profile of Eylea 2 mg. The long-term safety data did not show any new signals for any of the treatment groups including patients switching from Eylea 2 mg to Eylea 8 mg. The rates for ocular treatment emergent adverse events were similar in all treatment groups. No cases of occlusive vasculitis were reported. The rate for intraocular inflammation was low throughout the three years (1.4% in patients switched to Eylea 8 mg, and 1.5% in patients randomized at baseline to Eylea 2 mg).
These long-term data from PHOTON show the continued durable efficacy and safety of Eylea 8 mg. For patients and ophthalmologists this means reduced burden of disease with comparable efficacy and safety to the current standard of care Eylea 2 mg.
Eylea 8 mg is the only anti-VEGF treatment that is approved for treatment intervals of up to 5 months in DME and nAMD in major markets like the EU, UK, and Japan.
Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea 2 mg and Eylea 8 mg following any regulatory approvals.
About the PHOTON extension study
The aim of the open-label extension study was to evaluate long-term efficacy, safety and durability of Eylea 8 mg in patients with diabetic macular edema (DME) from week 96 until week 156. Patients previously treated with Eylea 2 mg could be switched to Eylea 8 mg and were immediately assigned to a 12-week dosing interval (no initial monthly doses needed). Patients that have already been treated with Eylea 8 mg throughout week 96 continued their last assigned interval. Disease activity was monitored every 4 weeks through week 108, then monitoring continued every 12 weeks. Disease activity was assessed according to specified, clinically relevant disease regimen modification (DRM) criteria. In patients with no disease activity the treatment interval was extended by 2-week increments with a maximum interval of 24 weeks (6 months). In patients with disease activity the treatment interval was shortened by 2-week increments with a minimum interval of 8 weeks (2 months).
About nAMD and DME
Neovascular (wet) age-related macular degeneration (nAMD) is an eye disease that progresses rapidly and if left untreated can lead to vision loss in a few months. nAMD is one of the leading causes of irreversible blindness and vision impairment around the world. nAMD may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. 170 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040. Approximately 10% of people with AMD will develop the advanced form nAMD.
Diabetic macular edema (DME) is a common complication in eyes of people living with diabetes. DME occurs when high levels of blood sugar lead to damaged blood vessels in the eye that leak fluid into the macula. This can lead to vision loss and, in some cases, blindness. Globally, 146 million people are currently living with diabetic retinopathy (DR), which can develop into a more serious condition which is diabetic macular edema. DME is affecting around 27 million people globally.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.
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Source: Bayer
